Posts Tagged Vioxx
Why Your Doctor’s Advice May Be Fatally Flawed
Posted by TheRedPillGuide in Big Pharma & Medical Mafia, Health, News on July 13, 2012
via: Mercola
by: Dr. Mercola
July 13, 2012
Curious about the prevalence and extent of scientific misconduct, researchers at the University of Illinois at Chicago’s Center for Pharmacoeconomic Research investigated the reasons why research studies were retracted, and from wherei.
The highest number of incidents of misconduct occurred in the drug literature, as compared to general biomedical literature. Nearly 75 percent of the retracted drug studies were attributed to scientific misconduct, which includes:
- Data falsification or fabrication
- Questionable veracity
- Unethical author conduct
- Plagiarism
This is a significant rise when compared to a 1998 review—cited in the featured NewsWise article—in which 37 percent of scientific retractions between 1966 and 1997 were due to scientific misconduct. Even more shocking: According to data from Thomson Reuters, the numbers of scientific retractions have climbed more than 15-fold since 2001ii!
The most unfortunate thing about this is that these are the types of studies many health care professionals rely on to make treatment recommendations. Large numbers of patients can be affected when false findings are published, as the average lag time between publication of the study and the issuing of a retraction is 39 months. And that’s if it’s ever caught at all.
Just How Scientific is “Science-Based Medicine” Really?
I am a big believer in the scientific method, provided it’s applied appropriately that is. And that’s the key issue here. In order to qualify in the first place, the research must be unbiased, unprejudiced and free from any significant conflicts of interest. Sadly, this is not the case with most of modern medicine—especially not when it comes to drug research, as evidenced by the featured findings.
It’s quite shocking that nearly three-quarters of all retracted drug studies are due to pure falsification of data. Especially when you consider that even well-researched drugs can still have significant side effects.
Just imagine the potential for tragedy when a drug is based largely on pure fantasy!
Vioxx is perhaps one of the better examples of what can happen when a drug is manufactured and sold under false pretenses. It killed more than 60,000 people in just a few years time, before it was removed from the market. In the case of Vioxx, there are lingering questions about the soundness of the research backing the drug in the first place. Back in 2008, Dr. Joseph S. Ross of New York’s Mount Sinai School of Medicine came across ghostwritten research studies for Vioxx while reviewing documents related to lawsuits filed against Merck.
According to an April 16, 2008 article on MedHeadlinesiii:
“In about 96 journal publications, Ross and his colleagues discovered internal Merck documents and e-mail messages pertaining to clinical study reports and review articles, some of which were developed by the company’s marketing department, not its scientific department. In others, there is little evidence that the authors recruited for the report made substantial contribution to the research itself. … Some of the authors listed in the Merck study reports of concern… question the true nature of ghostwriting. One neurologist originally listed as “External author?” and then listed as Dr. Leon J. Thal, of the University of California, San Diego in the final draft, died a year ago in an airplane crash.”
An editorial published in the Journal of the American Medical Association (JAMA)iv that year by Drs. Psaty and Kronmal also questioned whether Merck might have deliberately manipulated dozens of academic documents published in the medical literature, in order to promote Vioxx under false pretenses.
Avandia is another potent example. This diabetes medication hit the market in 1999 and quickly became a blockbuster drug. By 2006 its annual revenue was $3.2 billion. A year later, a damning study published in the New England Journal of Medicine (NEJM) linked Avandia to a 43 percent increased risk of heart attack and a 64 percent higher risk of cardiovascular death than patients treated with other methods.
Between 1999 and 2007, Avandia is estimated to have caused over 80,000 unnecessary heart attacksv, although the actual numbers of people harmed or killed by the drug is still largely unknown. The most recent analysis by the Cleveland Clinic in 2010vi, which used data from 56 clinical Avandia trials, calculated that for every 37 to 52 patients who take Avandia for five years, one additional heart attack can be expected as a result of the drug. As a result, the authors of this meta-analysis estimate the number of deaths caused by Avandia to be around 48,000, between 1999 and 2009.
This is a steep price, to say the least, for a disease that does not require drugs to begin with. Avandia is a poster child for the lethal paradigm of faux science as GlaxoSmithKline, the manufacturer of Avandia, hid damaging information about the drug for over 10 yearsvii, as it would adversely affect sales!
Again and again we are confronted with indisputable evidence that the drug paradigm is about money, not health, and certainly not dependable scientific inquiry.
Since that 2007 NEJM study, data from various trials, studies and meta-analyses have consistently confirmed the dangers of Avandia, and based on the evidence amassed over the past three years, the European Medicines Agency is now recommending the withdrawal of rosiglitazone-containing diabetic drugs due to the increased risk of ischaemic heart disease. NEJM also hit the nail on its head with the statement that,
“[T]he case of rosiglitazone underscores the need for a robust evidence base to demonstrate the safety of medicines administered long-term.”
Unfortunately, a committee of independent experts recommended that Avandia remain on the US market, despite its risks, and an FDA oversight board voted 8 to 7 to accept the advice.
It’s important to understand that our current medical system has been masterfully orchestrated by the drug companies to create a system that gives the perception of science when really it is a heavily manipulated process designed to manipulate and deceive you into using expensive and potentially toxic drugs that benefit the drug companies more than it benefits your health. Across the board, drugmakers do an excellent job of publicizing the findings they want you to know, while keeping very quiet about the rest.
It’s important to realize that all research is NOT published. And it should come as no surprise that drug studies funded by a pharmaceutical company that reaches a negative conclusion will rarely ever see the light of day… What this means is that even if you scour the medical literature to determine what the consensus is on any given medical topic, what you’ll find is an overwhelming preponderance of data in favor of the drug approach that in no way, shape or form reflects the reality of the scientific investigation that went into that specific drug.
How Drug Companies Manipulate Research Evidence to Fool You
The pharmaceutical industry as a whole has become the poster-child for fraud, deception, and manipulation of science for profit. Nearly 20 percent of the top 100 Corporate Criminals listed for the 1990s were in fact drug companies!
In an online series called Transparency and Medicine featured on the web site The Conversationviii, Jon Jureidini discusses how science-based medicine is clouded by marketing departments that control and distort information in the medical literature. Jureidini is a professor of psychiatry at the University of Adelaide (Australia), who got an inside look at this murky mess while examining drug company internal documents as an expert witness in a case against a pharmaceutical company. The voluminous amounts of documents he was given access to showed “serious misrepresentation” of both the effectiveness and safety of certain drugs, with published articles making the research appear positive, while negative secondary outcomes were deleted.
When you consider that this is the type of research data that then ends up being used to make treatment decisions for years to come by many expert review panels, is it any wonder the United States has the most expensive health care in the world, while STILL experiencing a decline in life expectancy and other health indexes? The whole idea that modern medicine is science-based has become laughable, as the evidence tells a whole different story…
Pfizer ‘Cherry-Picked’ Celebrex Data, Memos Say
Posted by TheRedPillGuide in Big Agriculture & Big Biotechnology, Big Pharma & Medical Mafia, FDA, Health, Monsanto, News on July 9, 2012
via: Mercola
by: Dr. Mercola
July 9, 2012
Celebrex is a type of nonsteroidal anti-inflammatory drug (NSAID) known as a COX-2 inhibitor.
Basically, it works by blocking COX-2 enzymes, which become overly active in your body when it becomes inflamed, and is widely used as a form of pain relief; in 2011, 2.4 million Americans received prescriptions for this drug.i
They may have thought twice, however, if they knew the truth behind how this drug came to be … a story that involves cherry-picking of data in attempts to make the drug seem superior to others on the market, when in fact it was not.
Also concerning: Celebrex is the only selective COX-2 inhibitor left on the market, as its close “cousins” were all pulled due to either their killing tens of thousands of people or to their unacceptably high heart risks …
Internal Memos Reveal Deception Surrounding Celebrex Data
New evidence in a lawsuit against Pfizer alleges that the drug company cherry-picked data on its drug Celebrex. Its claim to fame when it came on the market in 1998 was that it relieved pain without causing the gastrointestinal side effects common to other pain-relief drugs like ibuprofen.
Studies showed it didn’t necessarily relieve pain any better than the other drugs on the market, so Pfizer was counting on the gastrointestinal “ticket” to propel the drug into blockbuster status, and, in fact, used its easiness on your stomach as its primary selling point.
The problem was, Celebrex only appeared to be easier on the stomach because Pfizer, and its partner Pharmacia, only released the first six months of data from a year-long study. When the entire data set was looked at, the stomach “benefit” disappeared.
Folks this is what is called a blatant lie of omission and these companies do it on a regular basis. The system even encourages it. Contrary to what many people believe the FDA does no testing of drugs that are to be approved. Nor is there an objective third party that does tests. Rather the system the FDA employs has the drug company pay for and do the studies, and they only submit the studies that support the release of their drug. They are not required to submit failed ones.
That Pfizer withheld the critical data has been known for years, but newly unsealed documents showed this was all part of a carefully calculated plan by Pfizer and Pharmacia execs. While medical directors and scientists at the company expressed feeling uncomfortable with the “data massaging” and “cherry picking” of data, the powers that be moved full steam ahead with their deceptive marketing blitz.
Another reason that you might not be surprised about this report is that Pfizer purchased Monsanto and spun it off as subsidiary called Pharmacia in 1997.ii Most readers of this newsletter will instantly recognize that the bastion of evil, Monsanto, would not be out of place with this type of behavior.
The New York Times reported:iii
“The documents suggest that officials made a strategic decision during the early trial to be less than forthcoming about the drug’s safety. They show that executives considered attacking the trial’s design before they even knew the results and disregarded the advice of an employee and an outside consultant who had argued the companies should disclose the fact that they were using incomplete data.
… The documents show that in February 2000, Pharmacia employees came up with a game plan on how they might present the findings once they were available … Another document, a slide, proposed explaining poor results through “statistical glitches.”"
Do You Still Trust Celebrex?
Celebrex is still being widely used, often by arthritis patients who are desperate for pain relief. But even if you overlook the fact that it’s made by a company that clearly puts profits ahead of patients, it’s much harder to shrug off the very real risks it poses to your heart.
Remember, Celebrex is in the same class of drugs as Vioxx and Vioxx, both of which were pulled from the market because of serious heart risks or killing tens of thousands of people. Celebrex may still be on the market, but it is not immune to these risks!
In 2006, the New England Journal of Medicine released a study that discussed “a significant increase in adjudicated serious cardiovascular events with the use of celecoxib [Celebrex] … an increase in risk by a factor of two or three for … myocardial infarction, stroke, congestive heart failure, or cardiovascular-related death.” The risk was so severe that it “prompted suspension of the administration of celecoxib …”iv
Pfizer actually has a trial that’s ongoing right now that’s supposed to compare the heart risks of Celebrex to those of ibuprofen (Advil/Motrin) and naproxen (Aleve). But though it was started in 2005, it’s not slated to be completed until 2014 … the same year the Celebrex patent expires (at which point the company’s profits for the drug will dwindle … making negative study results far less impacting).
It’s widely known, however, that this painkiller has been linked to increased risks of stomach bleeding, kidney trouble, and liver damage – along with other adverse reactions that can range from mild to deadly. And it’s not at all unusual for a drug company to play up the “fabulous benefits” of their products while conveniently glossing over the fatalities they’ve caused … what would be unusual is if theydidn’t.
Common Diabetes Drugs Associated with Increased Risk of Death
New studies regularly reveal the true risks of many medications, including popular varieties that are used by millions of people. For example, an analysis of nearly 24,000 patients with type 2 diabetes found that three diabetes drugs – glipizide, glyburide, and glimepiride – caused a more than 50 percent greater risk of death compared to another diabetes drug, Metformin.v The three drugs are known as sulfonylureas, which work by spurring your body to produce more insulin.
The drugs not only increased the risk of death among all patients, but among those with heart disease (which is common among those with diabetes), glipizide increased the risk of death by 41 percent, and glyburide by 38 percent compared to Metformin.